Integrated data capture using aliasing schemes

ABSTRACT

Methods, systems, and computer-storage media are provided for using a generic aliasing scheme to facilitate electronic transcription of groups of clinical event data extracted from an electronic medical record to case report forms associated with clinical studies. The generic aliasing scheme is also used to electronically transcribe documentation of task completion to case report forms associated with the clinical studies.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.13/939,406, filed Jul. 11, 2013, entitled “Integrated Data Capture UsingAliasing Schemes”. The aforementioned application is hereby incorporatedby reference herein.

BACKGROUND

Clinical studies are scientific studies that test how a new medicine ora new treatment works in humans. Based on the outcomes of these studies,clinicians are able to find new and better ways to prevent, detect,diagnose, control, and treat diseases. Clinical studies often rely onclinical event data collected at healthcare facilities and stored inelectronic medical record (EMR) systems associated with the healthcarefacilities. Integrated data capture is used to electronically transcribeclinical event data culled from EMRs to case report forms associatedwith the clinical study. Previously, programs used by integrated datacapture systems specified only a limited number of discrete dataelements to pull from the EMR systems. If a clinical study required morethan this limited number of data elements, a custom program would haveto be created-a time-consuming and expensive endeavor. Moreover,previous programs were limited in that they were not designed to groupclinical event data together or gather data regarding task documentationfrom the EMR. For example, previous programs would be unable to gatherdata regarding whether informed consent was documented for a particularclinical study.

SUMMARY

This Summary is provided to introduce a selection of concepts in asimplified form that are further described below in the DetailedDescription. This Summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter. The present invention is defined by the claims.

In brief and at a high level, this disclosure describes, among otherthings, methods, systems, and computer-storage media for using aliasingschemes to facilitate electronic transcription of clinical event dataextracted from an EMR to case report forms associated with one or moreclinical studies. A generic aliasing scheme that is applicable tomultiple, disparate clinical studies is defined. The generic aliasingscheme comprises at least a first field for specifying a clinical eventtype or group such as, for example, “vital signs,” a second field forspecifying a particular item of clinical event data within the clinicalevent group, and an optional third field that specifies one or moresuffixes that describe how the clinical event data within the clinicalevent group is grouped after extraction from the EMR. The grouping maybe based on the time and date when the data was collected, arelationship between a set of data elements and a parent event, or onwhether a task was completed with respect to a data element. The groupsare presented to a user on a user interface, and the user can select oneor all of the groups to import to a case report form. Once a group(s) isselected, it is automatically imported to appropriate fields on the casereport form based on the specified aliasing scheme.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments are described in detail below with reference to the attacheddrawing figures, wherein:

FIG. 1 is a block diagram of an exemplary computing environment suitableto implement embodiments of the present invention;

FIG. 2 is a block diagram of an exemplary system for utilizing a genericaliasing scheme to facilitate electronic transcription of clinical eventdata extracted from an electronic medical record to case report formsassociated with clinical studies suitable to implement embodiments ofthe present invention;

FIG. 3 is a flow diagram of an exemplary method of using a specifiedaliasing scheme to group a set of clinical event data extracted from anEMR and using the specified aliasing scheme to facilitate electronictranscription of the set of clinical event data into one or more fieldsof a case report form in accordance with an embodiment of the presentinvention; and

FIG. 4 is a flow diagram of an exemplary method of generating a genericaliasing scheme, receiving inputs specifying parameters for the genericaliasing scheme, and using the specified aliasing scheme to facilitateelectronic transcription of groups of clinical event data extracted froman electronic medical record to one or more case report forms associatedwith disparate clinical studies in accordance with an embodiment of thepresent invention.

DETAILED DESCRIPTION

The subject matter of the present invention is described withspecificity herein to meet statutory requirements. However, thedescription itself is not intended to limit the scope of this patent.Rather, the inventors have contemplated that the claimed subject mattermight also be embodied in other ways, to include different steps orcombinations of steps similar to the ones described in this document, inconjunction with other present or future technologies. Moreover,although the terms “step” and/or “block” may be used herein to connotedifferent elements of methods employed, the terms should not beinterpreted as implying any particular order among or between varioussteps herein disclosed unless and except when the order of individualsteps is explicitly described.

Embodiments of the present invention are directed to methods, systems,and computer-storage media for using aliasing schemes to facilitateelectronic transcription of clinical event data extracted from an EMR tocase report forms associated with one or more clinical studies. Ageneric aliasing scheme that is applicable to multiple, disparateclinical studies is defined. The generic aliasing scheme comprises atleast a first field for specifying a clinical event type or group suchas, for example, “vital signs,” a second field for specifying aparticular item of clinical event data within the clinical event group,and an optional third field that specifies one or more suffixes thatdescribe how the clinical event data within the clinical event group isgrouped after extraction from the EMR. The grouping may be based on thetime and date when the data was collected, a relationship between a setof data elements and a parent event, or on whether a task was completedwith respect to a data element. The groups are presented to a user on auser interface, and the user can select one or all of the groups toimport to a case report form. Once a group(s) is selected, it isautomatically imported to appropriate fields on the case report formbased on the specified aliasing scheme.

An exemplary computing environment suitable for use in implementingembodiments of the present invention is described below. FIG. 1 is anexemplary computing environment (e.g., medical-informationcomputing-system environment) with which embodiments of the presentinvention may be implemented. The computing environment is illustratedand designated generally as reference numeral 100. The computingenvironment 100 is merely an example of one suitable computingenvironment and is not intended to suggest any limitation as to thescope of use or functionality of the invention. Neither should thecomputing environment 100 be interpreted as having any dependency orrequirement relating to any single component or combination ofcomponents illustrated therein.

The present invention might be operational with numerous other purposecomputing system environments or configurations. Examples of well-knowncomputing systems, environments, and/or configurations that might besuitable for use with the present invention include personal computers,server computers, hand-held or laptop devices, multiprocessor systems,microprocessor-based systems, set top boxes, programmable consumerelectronics, network PCs, minicomputers, mainframe computers,distributed computing environments that include any of theabove-mentioned systems or devices, and the like.

The present invention might be described in the general context ofcomputer-executable instructions, such as program modules, beingexecuted by a computer. Exemplary program modules comprise routines,programs, objects, components, and data structures that performparticular tasks or implement particular abstract data types. Thepresent invention might be practiced in distributed computingenvironments where tasks are performed by remote processing devices thatare linked through a communications network. In a distributed computingenvironment, program modules might be located in association with localand/or remote computer storage media (e.g., memory storage devices).

With continued reference to FIG. 1 , the computing environment 100comprises a computing device in the form of a control server 102.Exemplary components of the control server 102 comprise a processingunit, internal system memory, and a suitable system bus for couplingvarious system components, including data store 104, with the controlserver 102. The system bus might be any of several types of busstructures, including a memory bus or memory controller, a peripheralbus, and a local bus, using any of a variety of bus architectures.Exemplary architectures comprise Industry Standard Architecture (ISA)bus, Micro Channel Architecture (MCA) bus, Enhanced ISA (EISA) bus,Video Electronic Standards Association (VESA) local bus, and PeripheralComponent Interconnect (PCI) bus, also known as Mezzanine bus.

The control server 102 typically includes therein, or has access to, avariety of non-transitory computer-readable media. Computer-readablemedia can be any available media that might be accessed by controlserver 102, and includes volatile and nonvolatile media, as well as,removable and nonremovable media. By way of example, and not limitation,computer-readable media may comprise non-transitory computer storagemedia and communication media. Non-transitory computer storage mediaincludes both volatile and nonvolatile, removable and non-removablemedia implemented in any method or technology for storage of informationsuch as computer-readable instructions, data structures, program modulesor other data. Computer storage media includes, but is not limited to,RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM,digital versatile disks (DVD) or other optical disk storage, magneticcassettes, magnetic tape, magnetic disk storage or other magneticstorage devices, or any other medium which can be used to store thedesired information and which can be accessed by control server 102.Communication media typically embodies computer-readable instructions,data structures, program modules or other data in a modulated datasignal such as a carrier wave or other transport mechanism and includesany information delivery media. The term “modulated data signal” means asignal that has one or more of its characteristics set or changed insuch a manner as to encode information in the signal. By way of example,and not limitation, communication media includes wired media such as awired network or direct-wired connection, and wireless media such asacoustic, RF, infrared and other wireless media. Combinations of any ofthe above should also be included within the scope of computer-readablemedia.

The control server 102 might operate in a computer network 106 usinglogical connections to one or more remote computers 108. Remotecomputers 108 might be located at a variety of locations in a medical orresearch environment, including clinical laboratories (e.g., moleculardiagnostic laboratories), hospitals and other inpatient settings,veterinary environments, ambulatory settings, medical billing andfinancial offices, hospital administration settings, home healthcareenvironments, and clinicians' offices. Clinicians may comprise atreating physician or physicians; specialists such as surgeons,radiologists, cardiologists, and oncologists; emergency medicaltechnicians; physicians' assistants; nurse practitioners; nurses;nurses' aides; pharmacists; dieticians; microbiologists; laboratoryexperts; laboratory technologists; genetic counselors; researchers;veterinarians; students; and the like. The remote computers 108 mightalso be physically located in nontraditional medical care environmentsso that the entire healthcare community might be capable of integrationon the network. The remote computers 108 might be personal computers,servers, routers, network PCs, peer devices, other common network nodes,or the like and might comprise some or all of the elements describedabove in relation to the control server 102. The devices can be personaldigital assistants or other like devices.

Computer networks 106 comprise local area networks (LANs) and/or widearea networks (WANs). Such networking environments are commonplace inoffices, enterprise-wide computer networks, intranets, and the Internet.When utilized in a WAN networking environment, the control server 102might comprise a modem or other means for establishing communicationsover the WAN, such as the Internet. In a networking environment, programmodules or portions thereof might be stored in association with thecontrol server 102, the data store 104, or any of the remote computers108. For example, various application programs may reside on the memoryassociated with any one or more of the remote computers 108. It will beappreciated by those of ordinary skill in the art that the networkconnections shown are exemplary and other means of establishing acommunications link between the computers (e.g., control server 102 andremote computers 108) might be utilized.

In operation, an organization might enter commands and information intothe control server 102 or convey the commands and information to thecontrol server 102 via one or more of the remote computers 108 throughinput devices, such as a keyboard, a pointing device (commonly referredto as a mouse), a trackball, or a touch pad. Other input devicescomprise microphones, satellite dishes, scanners, or the like. Commandsand information might also be sent directly from a remote healthcaredevice to the control server 102. In addition to a monitor, the controlserver 102 and/or remote computers 108 might comprise other peripheraloutput devices, such as speakers and a printer.

Although many other internal components of the control server 102 andthe remote computers 108 are not shown, such components and theirinterconnection are well known. Accordingly, additional detailsconcerning the internal construction of the control server 102 and theremote computers 108 are not further disclosed herein.

Turning now to FIG. 2 , an exemplary computing system environment 200 isdepicted suitable for use in implementing embodiments of the presentinvention. The computing system environment 200 is merely an example ofone suitable computing system environment and is not intended to suggestany limitation as to the scope of use or functionality of embodiments ofthe present invention. Neither should the computing system environment200 be interpreted as having any dependency or requirement related toany single module/component or combination of modules/componentsillustrated therein.

The computing system environment 200 includes an aliasing service 210, ahealthcare facility 212 and its associated EMR system 214, a clientdevice 216, and two clinical studies 220 and 228, each with itsassociated case report forms, all in communication with one another viaa network 236. The network 236 may include, without limitation, one ormore local area networks (LANs) or wide area networks (WANs). Suchnetworking environments are commonplace in offices, enterprise-widecomputer networks, intranets, and the Internet. Accordingly, the networkis not further described herein.

In some embodiments, one or more of the illustrated components/modulesmay be implemented as stand-alone applications. In other embodiments,one or more of the illustrated components/modules may be integrateddirectly into the operating system of the aliasing service 210. Thecomponents/modules illustrated in FIG. 2 are exemplary in nature and innumber and should not be construed as limiting. Any number ofcomponents/modules may be employed to achieve the desired functionalitywithin the scope of embodiments hereof. Further, components/modules maybe located on any number of servers. By way of example only, thealiasing service 210 might reside on a server, a cluster of servers, ora computing device remote from one or more of the remaining components.

It should be understood that this and other arrangements describedherein are set forth only as examples. Other arrangements and elements(e.g., machines, interfaces, functions, orders, and groupings offunctions, etc.) can be used in addition to or instead of those shown,and some elements may be omitted altogether. Further, many of theelements described herein are functional entities that may beimplemented as discrete or distributed components or in conjunction withother components/modules, and in any suitable combination and location.Various functions described herein as being performed by one or moreentities may be carried out by hardware, firmware, and/or software. Forinstance, various functions may be carried out by a processor executinginstructions stored in memory.

The healthcare facility 212 may include, for example, hospitals,physician offices, nursing homes, urgent care clinics, and the like.Although only one healthcare facility is shown, it is contemplated thatthe present invention may encompass multiple healthcare facilities. Thehealthcare facility 212 treats patients, one or more of which may beenrolled in a clinical study such as clinical study 220 and/or clinicalstudy 228. In the course of a patient's treatment, clinical event datais collected by the healthcare facility 212 using one or moredocumentation applications. The clinical event data may be collected inthe ordinary course of treating the patient or in response to specificrequirements of a clinical study in which the patient is enrolled. Thetypes of clinical event data are numerous but representative examplesmay include vital signs, physical history, social history, medicationhistory, immunization history, adverse drug event data, laboratoryresults, radiograph results, and the like. After collection, theclinical event data is stored in association with the EMR system 214.

The healthcare facility 212 may be able to access the aliasing service210 in a variety of ways within the scope of the present invention. Forexample, in some embodiments, the healthcare facility 212 may have anative clinical computing system, which may be able to communicate withthe aliasing service 210. In other embodiments, a client applicationassociated with the aliasing service 210 may reside or partially resideon one or more of the healthcare facility's computing devicesfacilitating communication with the aliasing service 210. In furtherembodiments, communication may simply be a web-based communication,using, for example, a web browser to communicate to the aliasing service210 via the Internet. Any and all such variations are contemplated to bewithin the scope of embodiments of the present invention.

The healthcare facility's EMR system 214 may comprise electronicclinical documents such as images, clinical notes, orders, summaries,reports, analyses, or other types of electronic medical documentationrelevant to a particular patient's condition and/or treatment.Electronic clinical documents contain various types of clinical eventdata relevant to the condition and/or treatment of a particular patientand can include information relating to, for example, patientidentification information, images, alert history, culture results,physical examinations, vital signs, past medical histories, surgicalhistories, family histories, histories of present illnesses, current andpast medications, allergies, symptoms, past orders, completed orders,pending orders, tasks, lab results, other test results, clinical studiesin which the patient is currently enrolled or has been previouslyenrolled in, patient encounters and/or visits, immunizations, physiciancomments, nurse comments, other caretaker comments, and a host of otherrelevant clinical information.

The content and volume of such information in the data store 214 are notintended to limit the scope of embodiments of the present invention inany way. Further, though illustrated as a single, independent component,the data store 214 may, in fact, be a plurality of storage devices, forinstance, a database cluster.

As shown, the end-user computing device 216 includes a display screen218. The display screen 218 is configured to display information to theuser of the end-user computing device 216, for instance, informationrelevant to communications initiated by and/or received by the end-usercomputing device 216, clinical event data organized by group, and/or thelike. Embodiments are not intended to be limited to visual display butrather may also include audio presentation, combined audio/visualpresentation, and the like. The end-user computing device 216 may be anytype of display device suitable for presenting a graphical userinterface. Such computing devices may include, without limitation, acomputer, such as, for example, any of the remote computers 108described above with reference to FIG. 1 . Other types of displaydevices may include tablet PCs, PDAs, mobile phones, smart phones, aswell as conventional display devices such as televisions. Interactionwith the graphical user interface may be via a touch pad, a pointingdevice, and/or gestures.

Clinical study “1” 220 and clinical study “2” 228 represent one or moredisparate or related clinical studies in which patients, such aspatients cared for by the healthcare facility 212, are enrolled.Although only two clinical studies are shown, it is contemplated thatthe present invention may encompass numerous clinical studies. Theclinical studies 220 and 228 may be administered by organizations thatare separate from the healthcare facility 212 or by organizations thatare affiliated with the healthcare facility 212. Each clinical study 220and 228 may collect different types of clinical event data. For example,clinical study 220 may be studying the effects of a new medication onhumans and clinical study 228 may be studying the effectiveness of astroke prevention protocol. Each of these studies would likely collectdifferent types of clinical event data. Each clinical study 220 and 228has associated case report forms (e.g., case report forms 222, 224, and226 in the case of clinical study 220, and case report forms 230, 232,and 234 in the case of clinical study 228). After the appropriateclinical event data is extracted from the EMR 214 by the aliasingservice 210, the aliasing service 210 populates the data into differentfields on the case report forms

Like the healthcare facility 212, clinical study 220 and clinical study228 may be able to access the aliasing service 210 in a variety of wayswithin the scope of the present invention. For example, in someembodiments, the clinical studies 220 and 228 may have a native clinicalcomputing system, which may be able to communicate with the aliasingservice 210. In other embodiments, a client application associated withthe aliasing service 210 may reside or partially reside on one or moreof the clinical studies' computing devices facilitating communicationwith the aliasing service 210. In further embodiments, communication maysimply be a web-based communication, using, for example, a web browserto communicate to the aliasing service 210 via the Internet. Any and allsuch variations are contemplated to be within the scope of embodimentsof the present invention.

Components of the aliasing service 210 may include a processing unit,internal system memory, and a suitable system bus for coupling varioussystem components, including one or more data stores for storinginformation (e.g., files and metadata associated therewith). Thealiasing service 210 typically includes, or has access to, a variety ofcomputer-readable media.

The computing system environment 200 is merely exemplary. While thealiasing service 210 is illustrated as a single unit, it will beappreciated that the aliasing service 210 is scalable. For example, thealiasing service 210 may in actuality include a plurality of computingdevices in communication with one another. Moreover, the data store 214,or portions thereof, may be included within, for instance, the aliasingservice 210 as a computer-storage medium. The single unit depictions aremeant for clarity, not to limit the scope of embodiments in any form.

As shown in FIG. 2 , the aliasing service 210 comprises an aliasingcomponent 238, an extraction component 240, a presentation component242, a receiving component 244, and an importing component 246. In someembodiments, one or more of the components 238, 240, 242, 244, and 246may be implemented as stand-alone applications. In other embodiments,one or more of the components 238, 240, 242, 244, and 246 may beintegrated directly into the operating system of a computing device suchas the remote computer 108 of FIG. 1 . It will be understood that thecomponents 238, 240, 242, 244, and 246 illustrated in FIG. 2 areexemplary in nature and in number and should not be construed aslimiting. Any number of components may be employed to achieve thedesired functionality within the scope of embodiments hereof.

The aliasing component 238 of the aliasing service 210 is configured togenerate one or more generic aliasing schemes that can be used to groupclinical event data in ways that are useful to a wide variety ofdisparate clinical studies, such as clinical studies 220 and 228. Usinga generic aliasing scheme eliminates the need for clinical studies togenerate custom programs-saving both time and money.

The generic aliasing scheme generally includes a first field forspecifying an item group alias that describes a clinical event type orgroup, a second field for specifying an item alias that describes aparticular item of clinical event data, and an optional third field usedto specify a suffix that describes how the clinical event data withinthe clinical event group will be grouped. A data collection script canbe used to specify the aliases for the item groups and the items; thedata collection script maps to data locations in the EMR 214. Severalexamples will be provided to illustrate generic aliasing schemes andtheir applications. These examples are not meant to be limiting andadditional aliasing schemes beyond these examples are contemplated asbeing within the scope of the invention.

A generic aliasing scheme that is used to group clinical event databased on the time and the date when the data was collected and stored inthe EMR 214 includes:

<ITEM GROUP ALIAS>.<ITEM ALIAS>.DTTM

The same item group alias will be assigned to different items ofclinical event data that will be grouped together. The suffix “DTTM” isappended to the item alias and indicates that timestamp informationshould be extracted from the EMR 214 when the pieces of clinical eventdata corresponding to the item aliases are extracted, and that thetimestamp information should be used to group clinical event datacollected on the same day and at the same time.

As a practical example, a clinical study, such as the clinical study220, may wish to collect information about apical heart rate readingsand systolic blood pressure readings recorded for a patient enrolled inthe clinical study 220 and group the readings based on the day and timewhen they were recorded. Using the generic aliasing scheme providedabove, a user associated with the clinical study 220 specifies thefollowing aliasing schemes: VS.SYSBP.DTTM and VS.APHR.DTTM, where “VS”is the item group alias for vital signs, “SYSBP” and “APHR” are itemaliases for systolic blood pressure and apical heart rate, and “DTTM” isthe suffix. As explained further below, these aliasing schemes are usedto extract from the patient's EMR systolic blood pressure readings andtheir associated time stamps, and apical heart rate readings and theirassociated time stamps. Based on the suffix, those readings thatoccurred on the same day and at the same time will be grouped togetherunder the item group “vital signs.”

Another generic aliasing scheme that is used to indicate whether a taskassociated with a particular piece of clinical event data was completed,and, if not completed, the reason it was not completed, includes:

<ITEM GROUP ALIAS>.<ITEM ALIAS>.TASK

The same item group alias will be assigned to different clinical eventdata that will be grouped together. The suffix “TASK” is appended to theitem alias and indicates that task completion information, including thetime and date when the task was completed, will be extracted from theEMR 214 when the pieces of clinical event data corresponding to the itemaliases are extracted, and that the task completion information will beused to group the pieces of clinical event data under the clinical eventgroup. For instance, all pieces of clinical event data on which taskcompletion was documented and having the same item group alias will begrouped together. If a task was not completed for a particular piece ofclinical event data, the “TASK” suffix is additionally used to extractinformation from the EMR regarding the documented reason the task wasnot completed.

Using another practical example, the clinical study may wish to collectinformation about whether informed consent was obtained from the patientfor participation in the clinical study. Using the generic aliasingscheme for task completion, a user associated with the clinical studyspecifies the following aliasing scheme, “STUDYINFO.CONSENT.TASK,” where“STUDYINFO” is the item group alias for the clinical study and itsassociated case report form, “CONSENT” is the item alias for informedconsent, and “TASK” is the suffix that indicates that task completioninformation is needed. The aliasing scheme is used to extract from thepatient's EMR information regarding whether informed consent wasdocumented for the clinical study and, if informed consent wasdocumented, a date and time associated with the documentation. Ifinformed consent was not documented, the “TASK” suffix is used toextract any documented reasons why informed consent was not obtainedfrom the patient (e.g., the patient was unconscious and unable to giveinformed consent).

A third generic aliasing scheme generated by the aliasing component 238is used to group clinical event data collected together on the samedocumentation form. The clinical event data may be collected in a gridon the documentation form, or in individual cells on the documentationform. The third generic aliasing scheme corresponds to the followingformat:

<ITEM GROUP ALIAS>.<ITEM ALIAS>

In this case, the “item alias” in combination with the “item groupalias” indicates that clinical event data corresponding to the itemalias will be grouped under the clinical event group indicated by theitem group alias. For example, a documentation form used by a clinicianmay have a grid for documenting alcohol use. The grid may include fieldsfor alcohol frequency, alcohol type, and alcohol amount. To collect andgroup together information about alcohol frequency and alcohol amount,the administrator of the clinical study may specify the followingaliasing schemes: ALCOHOL.ALCOHOLFREQ and ALCOHOL.ALCOHOLAMT. Thesealiasing schemes will be used to extract clinical event data regardingalcohol frequency and alcohol amount from the grid on the documentationform and group the information together under alcohol use. In this case,the grid represents a subset of data items collected on the samedocumentation form.

In the case where a particular documentation form is used to gatherinformation, but the information is not part of a grid, the same genericaliasing scheme can be used. For example, a documentation form may beused by a clinician to gather a social history for the patient. The formmay have fields for marital status, smoking history, education level,and the like. The clinical study may be interested in informationregarding marital status and smoking history. The administrator mayspecify the following aliasing schemes: SOCIALHX.MARITAL andSOCIALHX.SMOKINGHX. The aliasing schemes are used to extract theindicated information from the social history documentation form andgroup the data together under social history.

Once the generic aliasing schemes have been generated by the aliasingcomponent 238, the receiving component 244 is configured to receiveinputs specifying, for example, specific item group aliases and itemaliases corresponding to input fields of a particular generic aliasingscheme. The inputs may be specified using, for example, data collectionscript and may be inputted by a user associated with a clinical studywho is seeking to collect information needed by the clinical study.

The extraction component 240 is configured to use the user-specifiedaliasing scheme(s) to extract clinical event data from the EMR 214 andgroup the data according to the specified aliasing scheme. In oneaspect, the clinical event data is stored in disparate locations withinthe EMR 214. In another aspect, the clinical event data is stored inassociation with a particular location within the EMR 214, such as aparticular documentation form.

The presentation component 242 is configured to present the extractedgroups of data on a user interface of a display device such as theclient device 216. Depending of the specified aliasing scheme(s), morethan one group of clinical event data may be presented. For instance,using the example given above regarding the aliasing scheme thatextracts systolic blood pressure and apical heart rate information fromthe EMR and groups the readings based on time and date of collection,one of the presented groups may correspond to vital sign readings takenat 8:00 am on Jun. 1, 2013, and another of the presented groups maycorrespond to vital sign readings taken at 12:00 pm on Jun. 1, 2013.

The receiving component 244 is configured to receive a user selection ofone or more of the presented groups. For example, the clinical study mayonly be interested in readings taken in the morning. The user is able tospecify that only the readings taken at 8:00 am on Jun. 1, 2013 shouldbe electronically transcribed into the case report form.

The importing component 246 is configured to electronically transcribeand/or import the selected group of clinical event data to one or morecase report forms associated with the clinical study. The importingcomponent 246 uses the specified aliasing scheme to determine whichfields on the case report form to import the selected group of data. Forinstance, the specified item group alias in the aliasing scheme may be“vitals,” and the particular case report form has a field correspondingto “vitals.” The importing component 246 uses the item group alias toimport the vitals group into the vitals field on the case report form.In a further example, the specified item group alias may be “vitalsigns” and the item alias may be “systolic blood pressure.” Theimporting component 246 uses both the item group alias and the itemalias to import the systolic blood pressure reading into the systolicblood pressure field under the vitals field on the case report form.

Turning now to FIG. 3 , FIG. 3 depicts a flow diagram of an exemplarymethod of using aliasing schemes to facilitate the electronictranscription of clinical event data extracted from an EMR to casereport forms associated with one or more clinical studies. The clinicalstudies may be disparate from one another and require different types ofclinical event data. Further, the clinical studies may require theclinical event data be grouped in a certain way or that task completionbe documented. The generic aliasing scheme described in the presentinvention can be used to meet these different needs without requiringthe clinical studies to generate their own custom programs.

At a step 310, inputs are received from, for example, a user associatedwith the clinical study, specifying an aliasing scheme that is used togroup a defined set of clinical event data that is stored in associationwith an EMR, such as the EMR 214 of FIG. 2 . For example, the inputs maycomprise an item group alias and one or more item aliases. Thus, the setof clinical event data specified by the item aliases is associated witha particular clinical event type or group specified by the item groupalias. The specified aliasing scheme may be derived from a genericaliasing scheme generated by an aliasing component such as the aliasingcomponent 238 of FIG. 2. The aliasing scheme may additionally include asuffix that describes how clinical event data will be grouped. The itemgroup alias and the item alias may be specified using one or more datacollection scripts such as, for example, CDASH nomenclature, that map toexisting data locations in the EMR.

As described above, suffixes may be used to indicate how the set ofclinical event data will be grouped. For example, the “DTTM” suffix isused to group the set of clinical event data based on a date and a timewhen the data was collected or recorded in the EMR. Another suffix, the“TASK” suffix, is used to group the set of clinical event data based onwhether one or more tasks associated with the set of clinical event datawere completed. Regarding task completion, if a task was not completedwith respect to a certain clinical event, the “TASK” suffix is also usedto extract information from the EMR about why the task was notcompleted. Although a suffix is not used, the set of clinical event datamay also be grouped based on a relationship between the data elementswithin the set and a parent event indicated by the item group alias.

At a step 312, the set of clinical event data is extracted from the EMRby an extraction component, such as the extraction component 240 of FIG.2 , and is grouped according to the specified aliasing scheme. At a step314, the groups are presented on a user interface by a presentationcomponent, such as the presentation component 242 of FIG. 2 . At a step316, a receiving component (such as the receiving component 244 of FIG.2 ) receives a selection of at least one of the presented groups. Theselection may be inputted by a user associated with the clinical study.At a step 318, the selected group is electronically transcribed orimported into one or more case report forms associated with the clinicalstudies by an importing component such as the importing component 246 ofFIG. 2 . The specified aliasing scheme is further used to facilitatethis process. For example, the aliases used in the specified aliasingscheme may correspond to descriptors associated with one or more fieldson the case report form. The importing component uses the specifiedaliasing scheme to direct where data in the selected group should beplaced on the case report form.

Turning now to FIG. 4 , a flow diagram is depicted of an exemplarymethod of generating a generic aliasing scheme, receiving inputsspecifying aliases for the generic aliasing scheme, and using thespecified aliasing scheme to facilitate electronic transcription ofgroups of clinical event data extracted from an electronic medicalrecord to one or more case report forms associated with disparateclinical studies. At a step 410, the generic aliasing scheme is definedby an aliasing component of an aliasing service such as the aliasingcomponent 238 of FIG. 2 . The generic aliasing scheme is useable by aplurality of disparate clinical studies and specifies ways to groupclinical event data stored in association with an EMR. The genericaliasing scheme comprises at least a first field used for specifying anitem group alias corresponding to a clinical event type or group, and asecond field used for specifying an item alias that corresponds to aspecific item of clinical event data. The generic aliasing scheme mayfurther include an optional third field located after the second fieldthat specifies a suffix that indicates how clinical event dataassociated with the clinical event group should be grouped.

At a step 412, a receiving component, such as the receiving component244 of FIG. 2 , receives one or more inputs specifying the item groupalias and the item alias. The inputs may be received from a userassociated with one of the clinical studies. At a step 414, clinicalevent data is extracted from the EMR based on the specified aliasingscheme, and the extracted data is grouped into one or more groupsaccording to the specified aliasing scheme. At a step 416, the groupsare presented on a user interface, and, at a step 418, a selection of atleast one of the groups is received. At a step 420, the selectedgroup(s) is imported into one or more of the case report forms. Thespecified aliasing scheme is used to determine an appropriate field(s)on the case report form to import the selected group.

The present invention has been described in relation to particularembodiments, which are intended in all respects to be illustrativerather than restrictive. Further, the present invention is not limitedto these embodiments, but variations and modifications may be madewithout departing from the scope of the present invention.

What is claimed is:
 1. One or more non-transitory computer-storage mediahaving computer-executable instructions embodied thereon that, whenexecuted, perform a method of using a generic aliasing scheme tofacilitate an electronic transcription of clinical event data extractedfrom an electronic medical record (EMR) to one or more case report formsassociated with a plurality of disparate clinical studies, wherein theplurality of disparate clinical studies are associated with a clinicalcomputing system, associated with a healthcare facility, forfacilitating communication with a central aliasing service residing on acomputing device, wherein the plurality of disparate clinical studiesare administered remote from the computing device, the methodcomprising: generating the generic aliasing scheme via the centralaliasing service by defining the generic aliasing scheme, wherein thegeneric aliasing scheme describes ways to group clinical event datastored in association with the EMR, wherein the EMR is accessible to thecentral aliasing service via a computer network, the generic aliasingscheme useable by the plurality of disparate clinical studies, thegeneric aliasing scheme comprising at least: a first field forspecifying an item group alias corresponding to a clinical event group;and a second field for specifying an item alias corresponding to an itemof clinical event data within the clinical event group; generating, viathe central aliasing service, a first case report form associated with afirst clinical study of the plurality of disparate clinical studiesutilising the generic aliasing scheme by: receiving, via a receivingcomponent of the central aliasing service, a first input specifying theitem group alias for the first field and a second input specifying theitem alias for the second field to generate a first specified aliasingscheme; extracting, via an extraction component of the central aliasingservice, a first set of clinical event data from the EMR based on thefirst specified aliasing scheme; grouping the extracted first set of theclinical event data into one or more first groups based on the firstspecified aliasing scheme; presenting, via a presentation component ofthe central aliasing service, the one or more first groups on a userinterface; receiving, via the receiving component of the centralaliasing service, a first selection of at least one of the one or morefirst groups; automatically importing, via an importing component of thecentral aliasing service, the first selection into the determined firstplacement on first case report form, wherein automatically importing thefirst selection comprises using the first specified aliasing scheme todirect the placement of the first selection into the determined firstplacement on the first case report form; and based on receiving thefirst specified aliasing scheme, determining a first placement, on thefirst case report form, for the at least one of the one or more firstgroups associated with the first selection; generating, via the centralaliasing service, a second case report form associated with a secondclinical study of the plurality of disparate clinical studies utilisingthe generic aliasing scheme by: receiving, via the receiving componentof the central aliasing service, a third input specifying the item groupalias for the first field and a fourth input specifying the item aliasfor the second field to generate a second specified aliasing scheme;extracting, via the extraction component of the central aliasingservice, a second set of clinical event data from the EMR based on thesecond specified aliasing scheme; grouping the extracted second set ofthe clinical event data into one or more second groups based on thesecond specified aliasing scheme; presenting, via the presentationcomponent of the central aliasing service, the one or more second groupson the user interface; receiving, via the receiving component of thecentral aliasing service, a second selection of at least one of the oneor more second groups; automatically importing, via the importingcomponent of the central aliasing service, the second selection into thedetermined second placement on the second case report form, whereinautomatically importing the second selection comprises using the secondspecified aliasing scheme to direct the placement of the secondselection into the determined second placement on the second case reportform; and in response to receiving the second specified aliasing scheme,determining a second placement, on the second case report form, for theat least one of the one or more second groups associated with the secondselection.
 2. The media of claim 1, wherein the extracted first set ofthe clinical event data is grouped based on a relationship between thefirst set of the clinical event data and the clinical event group of thespecified item group alias for the first field.
 3. The media of claim 1,the generic aliasing scheme further comprising a third field thatspecifies a suffix that indicates how the clinical event data will begrouped.
 4. The media of claim 3, wherein a suffix “dttm” indicates thatthe first set of the clinical event data be grouped based on whether thefirst set of the clinical event data was recorded in the EMR on a sameday and at a same time.
 5. The media of claim 3, wherein a suffix “task”indicates that the first set of the clinical event data be grouped basedon whether a task associated with the first set of the clinical eventdata was completed.
 6. The media of claim 1, wherein the first specifiedaliasing scheme is further used to determine an appropriate field on thefirst case report form to import the first selection.
 7. The media ofclaim 5, wherein the task for a subset of the first set of the clinicalevent data was incomplete, and wherein, based on the suffix “task”,extracting the first set of the clinical event data includes extractinga documented reason for the incomplete task from the EMR for the subsetof the first set of the clinical event data.
 8. The media of claim 7,wherein the incomplete task is incomplete informed consent and thedocumented reason includes why informed consent was not obtained from apatient.
 9. The media of claim 1, wherein the first set of the clinicalevent data is different from the second set of the clinical event data.10. A method for generating one or more case report forms associatedwith a first clinical study, wherein the first clinical study isassociated with a clinical computing system, associated with ahealthcare facility, for facilitating communication with a centralaliasing service residing on a computing device, wherein the firstclinical study is administered remote from the computing device, whereinthe one or more case report forms are generated based on a genericaliasing scheme that describes ways to group clinical event data storedin association with an electronic medical record (EMR), the methodcomprising: receiving, via a receiving component of the central aliasingservice in communication with the EMR via a computer network, a firstinput specifying an item group alias for a first field, wherein the itemgroup alias corresponds to a clinical event group; receiving, via thereceiving component of the central aliasing service, a second inputspecifying an item alias for a second field, wherein the item aliascorresponds to an item of the clinical event data within the clinicalevent group; generating, via the central aliasing service, a specifiedaliasing scheme based on the received first input and the receivedsecond input; extracting, via an extraction component of the centralaliasing service, the clinical event data from the EMR and based on thespecified aliasing scheme; grouping, via the central aliasing service,the extracted clinical event data into one or more groups, wherein atleast one of the one or more groups was grouped based on an incompletetask associated with the clinical event data; determining a placement,on the one or more case report forms, for the one or more groups basedon the specified aliasing scheme; and automatically importing, via animporting component of the central aliasing service, the one or moregroups into the determined placement on the one or more case reportforms for presentation, wherein automatically importing the one or moregroups comprises using the specified aliasing scheme to direct theplacement of the one or more groups into the determined placement on theone or more case report forms, wherein at least one of the one or morecase report forms provides a reason for the incomplete task.
 11. Themethod of claim 10, wherein the reason is a documented reason as to whyconsent was not received from a patient.
 12. The method of claim 10further comprising: receiving a third input for a third field thatspecifies a suffix; and generating the specified aliasing scheme basedon the received first input, the received second input, and the receivedthird input.
 13. The method of claim 10, wherein the item group aliasand the item alias are specified using one or more data collectionscripts that map to existing data locations in the EMR.
 14. The methodof claim 10, wherein at least one of the one or more groups was groupedbased on a relationship between the item of the clinical event data andthe clinical event group.
 15. The method of claim 10, wherein aliases inthe specified aliasing scheme correspond to descriptors associated withfields on the one or more case report forms.
 16. The method of claim 10,wherein one of the specified item group alias is “vital signs” and theitem alias is “systolic blood pressure”.
 17. The method of claim 16,wherein both the item group alias and the item alias cause the importingof the systolic blood pressure into a systolic blood pressure fieldunder a vitals field on one of the one or more case report forms.
 18. Acomputer system useful for creating case report forms, the systemcomprising: a non-transitory memory device for storing computer readableprogram code; and a processor in communication with the memory device,the processor being operative with the computer readable program codeto: define, via a central aliasing service residing on a computingdevice, a generic aliasing scheme based on communication with anelectronic medical record (EMR) that is in communication with thecentral aliasing service via a computer network, the generic aliasingscheme comprising: a first field for specifying an item group aliascorresponding to a clinical event group; and a second field forspecifying an item alias corresponding to an item of clinical event datawithin the clinical event group; generate, via the central aliasingservice, a first case report form associated with a first clinicalstudy, wherein the first clinical study is associated with a clinicalcomputing system, associated with a healthcare facility, forfacilitating communication with the central aliasing service, whereinthe first clinical study is administered remote from the computersystem, generating the first case report comprises utilising the genericaliasing scheme by: receiving, via a receiving component of the centralaliasing service, a first input specifying the item group alias;receiving, via the receiving component, a second input specifying theitem alias; generating, via the central aliasing service, a firstspecified aliasing scheme using the first input and the second input;extracting, via an extraction component of the central aliasing service,a first set of clinical event data based on the first specified aliasingscheme; grouping, via the central aliasing service, the extracted firstset of the clinical event data into one or more first groups;determining a first placement, on the first case report form, for theone or more first groups based on the first specified aliasing scheme;and automatically importing, via an importing component of the centralaliasing service, at least one of the one or more first groups into thedetermined first placement on the first case report form, whereinautomatically importing the at least one of the one or more first groupscomprises using the first specified aliasing scheme to direct theplacement of the at least one of the one or more first groups into thedetermined placement on the first case report form; generate, via thecentral aliasing service, a second case report form associated with asecond clinical study utilising the generic aliasing scheme by:receiving, via the receiving component, a third input specifying theitem group alias for the first field; receiving, via the receivingcomponent, a fourth input specifying the item alias for the secondfield; generating, via the central aliasing service, a second specifiedaliasing scheme using the third input and the fourth input; extracting,via the extraction component, a second set of clinical event data fromthe EMR based on the second specified aliasing scheme; grouping, via thecentral aliasing service, the extracted second set of the clinical eventdata into one or more second groups; determining a second placement, onthe second case report form, for the one or more second groups based onthe second specified aliasing scheme; and automatically importing, viathe importing component, at least one of the one or more second groupsinto the determined second placement on the second case report form,wherein automatically importing the at least one of the one or moresecond groups comprises using the second specified aliasing scheme todirect the placement of the at least one of the one or more secondgroups into the determined placement on the second case report form. 19.The system of claim 18, wherein the generic aliasing scheme furthercomprises a third field that specifies a suffix.
 20. The system of claim19, wherein the first field specifies alcohol frequency, the secondfield specifies alcohol type, and the third field specifies alcoholamount.